FDA Approves Pivya (pivmecillinam) for the Treatment of Uncomplicated Urinary Tract Infections
April 24, 2024 -- Today, the U.S. Food and Drug Administration approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 24, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Grants Accelerated Approval for Ojemda (tovorafenib) for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma
BRISBANE, Calif., April 23, 2024 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One” or the“Company”), a commercial-stage biopharmaceutical company dedicated to developing and commercializing... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 23, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Approves Anktiva (nogapendekin alfa inbakicept-pmln) Plus BCG for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
CULVER CITY, Calif., April 22, 2024 -- ImmunityBio, Inc. (NASDAQ: IBRX), an immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has approved Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 22, 2024 Category: Drugs & Pharmacology Source Type: news
U.S. FDA Approves Subcutaneous Administration of Takeda ’s Entyvio (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Crohn’s Disease
OSAKA, Japan April 19, 2024 and CAMBRIDGE, Massachusetts, April 18, 2024– Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved Entyvio® (vedolizumab) subcutaneous (SC) administration for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 18, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Approves Lumisight (pegulicianine) Optical Imaging Agent to Illuminate Residual Breast Cancer Post-Lumpectomy
NEWTON, Mass.--(BUSINESS WIRE) April 18, 2024 --Lumicell, Inc., a privately held company focused on developing innovative fluorescence-guided imaging technologies for cancerous tissue detection during surgery, today announced the U.S. Food&... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 18, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Approves Genentech's Alecensa as First Adjuvant Treatment for People With ALK-Positive Early-Stage Lung Cancer
South San Francisco, CA -- April 18, 2024 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Alecensa® (alectinib) for adjuvant treatment... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 18, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Approves Selarsdi (ustekinumab-aekn), a Biosimilar to Stelara
REYKJAVIK, Iceland& PARSIPPANY, N.J.--(BUSINESS WIRE) April 16, 2024 --Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 16, 2024 Category: Drugs & Pharmacology Source Type: news
Fasenra Approved for Treatment of Children Aged 6 to 11 with Severe Asthma
WILMINGTON, Del.--(BUSINESS WIRE) April 11, 2024 --AstraZeneca’s Fasenra® (benralizumab) is now approved by the US Food and Drug Administration (FDA) for add-on maintenance treatment for patients with severe asthma aged 6 to 11 with an... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 11, 2024 Category: Drugs & Pharmacology Source Type: news
Xcopri (cenobamate) Receives FDA Approval for Alternate Methods of Administration That Include Crushed Tablet in Liquid Suspension Taken Orally or Through a Nasogastric Tube
PARAMUS, N.J., April 11, 2024 /PRNewswire/ -- SK Life Science, Inc., a U.S. pharmaceutical company developing treatments that will change the future of central nervous system (CNS) disorders and a subsidiary of SK Biopharmaceuticals, Co., Ltd.,... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 11, 2024 Category: Drugs & Pharmacology Source Type: news
ViiV Healthcare Announces U.S. FDA Approval of Dovato (dolutegravir/lamivudine) for Adolescents Living with HIV
Durham, NC, April 8, 2024– ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the U.S. Food and Drug Administration (FDA) approved Dovato... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 8, 2024 Category: Drugs & Pharmacology Source Type: news
Enhertu Approved in the US as First Tumor-Agnostic HER2-Directed Therapy for Previously Treated Patients with Metastatic HER2-Positive Solid Tumors
April 6, 2024 -- AstraZeneca and Daiichi Sankyo ' s Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 6, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Approves Carvykti for Patients with Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy
HORSHAM, PA (April 5, 2024)– Johnson& Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved Carvykti® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 5, 2024 Category: Drugs & Pharmacology Source Type: news
U.S. FDA Approves Abecma for Triple-Class Exposed Relapsed or Refractory Multiple Myeloma After Two Prior Lines of Therapy
PRINCETON, N.J.,& CAMBRIDGE, Mass.--(BUSINESS WIRE) April 05, 2024 -- Bristol Myers Squibb (NYSE: BMY) and 2seventy bio, Inc. (Nasdaq: TSVT) have announced that on April 4, 2024, the U.S. Food and Drug Administration (FDA) approved Abecma®... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 5, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Approves Zevtera (ceftobiprole medocaril sodium) for Bacteremia, Skin and Skin Structure Infections, and Pneumonia
Allschwil, Switzerland, April 04, 2024 -- Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 4, 2024 Category: Drugs & Pharmacology Source Type: news
Vanda Pharmaceuticals' Fanapt (iloperidone) Receives U.S. FDA Approval for the Acute Treatment of Bipolar I Disorder
WASHINGTON, April 2, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved Fanapt (iloperidone) tablets for the acute treatment of manic or mixed episodes... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 2, 2024 Category: Drugs & Pharmacology Source Type: news
